MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,litera report with the FDA on 2018-12-13 for ADVIA CENTAUR XP VB12 ASSAY N/A 10309970 manufactured by Siemens Healthcare Diagnostics, Inc..
[130494293]
Siemens is filing the mdr conservatively as there is limited information provided. According to the case report, the possible cause is interference from a high titre of instrinsic factor antibody. Siemens healthcare diagnostics is investigating. Mdr 2432235-2018-00455 was also filed for the immulite platform.
Patient Sequence No: 1, Text Type: N, H10
[130494294]
In a case report from 2012, the advia centaur vb12 assay was reported to show normal results that were discordant with the clinical picture of the patient. The patient's clinical appearance is one of b12 deficiency. The (b)(6)-year old woman with severe anaemia (haemoglobin 58 g/l) who had been suffering from progressively increasing palpitations, profound fatigue and exertional dyspnoea for about one month was admitted to the hospital in (b)(6) 2011. The vitamin b12 and folate deficiency were considered immediately. However, the results were in the normal range. The patient received two red cell units and was discharged from the hospital. Two weeks later, the patient was admitted again with anemia based on hemoglobin levels, and when tested for vitamin b12 levels the results were in the normal range. It was decided at this point to treat the patient with a pharmacological dose of subcutaneous vitamin b12. After 2 weeks, the patient's condition improved and complete clinical and haematological recovery occurred within the next month. There was no report of adverse health consequences due to the discordant vb12 results with the clinical picture.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219913-2018-00303 |
| MDR Report Key | 8162181 |
| Report Source | COMPANY REPRESENTATIVE,LITERA |
| Date Received | 2018-12-13 |
| Date of Report | 2019-01-07 |
| Date of Event | 2011-05-01 |
| Date Mfgr Received | 2018-12-19 |
| Date Added to Maude | 2018-12-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. EIMAN SULIEMAN |
| Manufacturer Street | 333 CONEY STREET |
| Manufacturer City | E. WALPOLE MA 02032 |
| Manufacturer Country | US |
| Manufacturer Postal | 02032 |
| Manufacturer Phone | 5086604603 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
| Manufacturer Street | 333 CONEY STREET |
| Manufacturer City | E. WALPOLE MA 02032 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02032 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA CENTAUR XP VB12 ASSAY |
| Generic Name | VB12 IMMUNOASSAY |
| Product Code | CDD |
| Date Received | 2018-12-13 |
| Model Number | N/A |
| Catalog Number | 10309970 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
| Manufacturer Address | 511 BENEDICT AVENUE TARRYTOWN NY 105915097 US 105915097 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-13 |